Events

Recall of OHIO FREE-FLOW SUCTION REGULATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OHMEDA MEDICAL A DIVISION OF DATEX OHMEDA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22807
  • Event Risk Class
    II
  • Event Initiated Date
    2001-10-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Three mode vacuum regulator has been mistakenly labeled as a two mode cvr and this unit can be set to max and deliver the full vacuum present on the wall outlet independently of the vacuum adjusting knob.

Device

OHIO FREE-FLOW SUCTION REGULATOR

Manufacturer

OHMEDA MEDICAL A DIVISION OF DATEX OHMEDA INC.
  • Manufacturer Address
    LAUREL
  • Source
    HC